"But adding a nameplate does not double the staff numbers. "
But Ronald, surely you are not questioning the MHRA's claim about doubling Approved Body capacity?
As usual, you have hit the nail on the head. Those of us in the real world, optimists or not, can see that things are not going smoothly. At the moment, I doubt the bookmakers would give good odds for 'continued acceptance of CE marked medical devices and IVDs' being part of the new framework.
Although specialist collectors may be on the lookout for products bearing the lesser-spotted CE UKNI marking.
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Ed Ball
Manager, Intelligence & Innovation
United Kingdom
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Original Message:
Sent: 15-Jan-2024 02:11
From: Ronald Boumans
Subject: MHRA Update on UKCA Marking
If the MHRA want to see UKCA marking become mandatory, there must be adequate capacity from UK Approved Bodies. RIght now, there are six designated. But adding a nameplate does not double the staff numbers. The same people that are now busy with the MDR and IVDR will also be needed for UKCA marking. Right now, non of those six approved bodies are designated for the new requirements. Unless the new UKCA requirements are identical to MDR/IVDR, they need to make serious investments in UKCA marking. They will only do this, if they expect that investment will pay out. If most manufacturers will say that they will wait until they really, really have to switch, it does not look like a good business opportunity for the UK approved bodies. Likewise, if there are no UK Approved Bodies designated for the new regulations, no manufacturer can get certified. For other UKCA marked products (e.g. PPE) this has already happened and manufacturers and certification bodies that did prepare saw their investments evaporate overnight.
This is a prisoners dilemma. If the whole industry goes on 'regulatory burden strike', UKCA will not become mandatory, unless UKCA mainly involves some rubber stamps on a CE-certificate.
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Ronald Boumans
MDR Expert
Super PRRC
Netherlands
Original Message:
Sent: 10-Jan-2024 04:03
From: Abiola Bamigbade
Subject: MHRA Update on UKCA Marking
In case anyone is on the look-out for information on UKCA Marking.
The MHRA released a recent publication titled - Roadmap towards the future regulatory framework for medical devices. In reality, the roadmap still look murky; most things are still up in the air regarding how the UKCA Marking will unfold in the coming years. Also, 2024 is an election year in the UK, so who knows?
The roadmap is attached, hopefully it can aid individual firm's regulatory strategy formulation as the new year kicks-off, even if it means - do nothing on this for now!
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Abi Bamigbade
Head of Quality and Regulatory Affairs
Kays Medical Ltd, UK.
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